Phase II, multi-centered, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety of recombinant human Epidermal Growth Factor (rhEGF) at a dose of 25 or 75 micrograms intralesionally 3 times a week for up to 12 weeks, in patients with diabetic foot ulcer (Wagner grade 1 or 2).

Center for Genetic Engineering and Biotechnology (CIGB), Havana.0 个研究点目标入组 35 人开始时间: 2010年12月24日最近更新: 2024年8月19日

适应症

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1) Patients with DM type 1 or 2 under ADA criteria. 2) Patients of both sexes, aged >= 18. 3) Diabetic foot ulcers classified by Wagner as grade 1 covering an area >10 and =50 cm2 or grade 2 covering an area >1 and =50 cm2. 4) Neuropathic ulcer evidenced by palpable distal pulses and ankle/arm index (AA/I) = 0.8 and < 1.3. If arterial calcification occurs (AA/I = 1.3), the finger/arm index (FA/I) will be used. It should not exceed 0.7. 5) Ulcer = 4 week evolution. 6) Reproductive age men and women should use effective contraceptive methods for up to three months after completing treatment. 7) Patients should give their consent.

•1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Connective tissue diseases. 5. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin and other growth factors) in the previous 3 weeks. 6. Uncontrolled systemic or serious diseases: cardiopathies (acute myocardial infarction < 3 months, unstable angina or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values > 200mmol/L. 7. Clinical malnutrition signs or albumin levels < 30 g/L. 8. Hemoglobin < 100g/L. 9. Hypersensitivity to the product or any of its components. 10. History of current or past neoplasia. 11. Failure to conduct relevant evaluations or keep appropriate drainage in affected limb. 12. Previous intralesional EGF treatment in current lesion or < 4 weeks in any other lesion, or topical EGF < 4 weeks in current lesion. 13. Psychiatric or neurological diseases preventing informed consent. 14. History of alcoholism or drug addiction one year prior to inclusion. 15. Pregnancy or breastfeeding.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), Havana.